BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 17955412 · Received October 18, 2023

    Report

    Report Number
    2955842-2023-19329
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    September 18, 2023
    Report Date
    September 18, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON REPORTED THAT THE INSTRUMENT WAS BLINDLY PLACED INTO THE PATIENT'S ABDOMEN RESULTING IN A BOWEL INJURY. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DA VINCI XI SYSTEM USER MANUAL CONTAINS THE FOLLOWING STATEMENTS REGARDING INSTRUMENT INSTALLATION: WARNING: INSERT AND EXCHANGE INSTRUMENTS UNDER VISION TO PREVENT TISSUE INJURY. WARNING: MAKE SURE THE SURGEON CONSOLE OPERATOR IS READY TO RESUME CONTROL OF THE INSTRUMENT BEFORE INSERTING AN INSTRUMENT INTO THE STERILE FIELD TO PREVENT TISSUE INJURY. THE DA VINCI X/XI INSTRUMENTS AND ACCESSORIES USER MANUAL CONTAINS THE FOLLOWING STATEMENTS REGARDING INSTRUMENT INSTALLATION: USE CAUTION AND VIEW THE INSTRUMENT TIP WITH THE ENDOSCOPE WHEN MANUALLY INSERTING AN INSTRUMENT INTO THE PATIENT. WARNING: DO NOT MANIPULATE INSTRUMENTS THAT ARE OUTSIDE THE SURGEON'S FIELD OF VIEW, TO PREVENT PATIENT TISSUE DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS BLINDLY PLACED INTO THE PATIENT'S ABDOMEN AND INJURED THE BOWEL. THE SURGEON REPORTED THAT THE INJURY FROM THE MCS RESULTED IN A SMALL BOWEL LACERATION THAT REQUIRED STAPLING TO CLOSE IT. THE SURGEON WAS ABLE TO REPAIR THE INJURY ROBOTICALLY. NO ADDITIONAL TISSUE RESECTION WAS REQUIRED, AND NO ADDITIONAL BLEEDING OCCURRED DUE TO THE INJURY. NO ADDITIONAL TESTING WAS REQUIRED. THE PATIENT IS RECOVERING WELL AND DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586966 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES